Evaluation of the effect of Olibanum resin on improvement of mild to moderate Alzheimer's disease
Design
30 sample size RCT in tow parallel group placebo&Control, Double-Blind, Block Randomization using the websitewww.Randomization.com
Settings and conduct
Alzheimer's patients referring to clinic of Avicenna's hospital in Mashhad if they have inclusion criteria after the signature of the informed consent form by legal guardians are randomly and doubel blind (such as Researchers, clinical caregivers, patients, outcome evaluator, and data analyzer) divided into two groups of 15 treatment and placebo; after Receiving capsules for 12 weeks; Mental status of both groups is studying with MMSE and CDR tests and compared to week zero Using SPSS.16 software.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients with mild to moderate Alzheimer's disease based on the score of the MMSE test= 10-23
Exclusion criteria: Diagnosis of Alzheimer's disease less than 6 months before entering the study, Using cholinesterase inhibitors and / or memantine less than90 days before entering the study or discontinuing them less than 90 days before entering the study, Use of other drugs and substances that affect cognitive status less than 60 days before entering the study or discontinued less than 90 days before entering the study, Vascular dementia, thyroid disease, vitamin B12 deficiency, anemia, Lewy body dementia, liver function disorders, brain tumors, ischemic CVA
Intervention groups
Intervention group: A capsule containing 750 mg of Olibanum resin is taken orally three times per day for 12 weeks.
Control group: The placebo is used like Olibanum in the form of capsules are apparently similar to the study drug , which contains 500 mg of starch powder. Capsules are provided by the Pharmacy Department of Herbal Drugs at Imam Reza Pharmacy in Mashhad
Main outcome variables
Cognitive status
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161219031463N2
Registration date:2019-03-09, 1397/12/18
Registration timing:retrospective
Last update:2019-03-09, 1397/12/18
Update count:0
Registration date
2019-03-09, 1397/12/18
Registrant information
Name
Hamid Reza Sadeghnia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 8566
Email address
sadeghniahr@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-09, 1397/07/17
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of adding Boswellia serrata resin to therapy of patients with mild to moderate Alzheimer's disease on cognitive status compared with placebo
Public title
Improving effects of olibanum on learning and memory
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with mild to moderate Alzheimer's disease based on the score of the MMSE test between 10-23
Exclusion criteria:
Diagnosis of Alzheimer's disease less than 6 months before entering the study
Using cholinesterase inhibitors and / or memantine less than 90 days before entering the study or discontinuing them less than 90 days before entering the study
Use of other drugs and substances such as ginkgo biloba or vitamin E that affect cognitive status less than 60 days before entering the study or discontinued less than 90 days before entering the study.
Vascular dementia, thyroid disease, vitamin B12 deficiency, anemia, Lewy body dementia, liver function disorders, brain tumors, ischemic cerebrovascular accidents
Age
From 55 years old to 82 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was done individually, block and using the website www.Randomization.com with 6 subjects per block. This was done by an indipendent researcher and was given to the capsule deliverer by naming the unknown letters that the person did not know the original name of the capsules named in letters.
Blinding (investigator's opinion)
Double blinded
Blinding description
Groups as paticpants, clinical care givers, outcome evaluators and data analyzer are not aware of the presence of samples in the control group of the placebo or the study group. So that the duty of dividing the patients into two groups was performed by the person who was not dependent on the study, and the distribution of the drug and placebo was done by the same person, and until the end of the study, information about the grouping of patients was reserved by this person
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Mashhad University of Medical Sciences
Street address
Ghershi building, Daneshgah Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Approval date
2016-12-18, 1395/09/28
Ethics committee reference number
IR.HUHS.REC.1395.438
Health conditions studied
1
Description of health condition studied
Alzheimer's disease
ICD-10 code
F00
ICD-10 code description
Dementia in Alzheimer disease
Primary outcomes
1
Description
Cognitive status
Timepoint
Study of cognitive status at the beginning of the study (before the intervention) and 12 weeks after the start of use of capsule containing Olibanum resin or placebo
Method of measurement
Using MMSE and CDR tests
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A capsule containing 750 mg of Olibuma resin is taken orally three times per day for 12 weeks. Capsules are provided by the Pharmacy Department of Herbal Drugs at Imam Reza Pharmacy in Mashhad
Category
Treatment - Drugs
2
Description
Control group: The placebo is used in the form of capsules are apparently similar to the study drug , which contains 500 mg of starch powder three times a day for 12 weeks orally. Capsules are provided by the pharmacy department of Herbal Drugs at Imam Reza Pharmacy in Mashhad
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ebne Sina hospital
Full name of responsible person
َAli Manteghi
Street address
Next to Astan Ghods Razavi's transition, Horr Ameli Blv.